Medical Device Consultants

Regulatory and Technical Associates, Inc. has provided Medical Device Consulting Services for over twenty years. Our medical device consultants are focused on providing regulatory and preclinical consulting services, and the Investigational Review Board clinical protocol review services required by our clients to achieve and maintain US and international approval of their medical devices, medical device packaging materials and drug/device combination products.

Our Medical Device Consultants, Dr. Robert J. Staab and Dr. Ira W. Daly, each have over 35 years of experience guiding clients through the regulatory hurdles of medical device evaluation and US and international registration. Dr. Staab and Dr. Daly are Board Certified in toxicology, and in regulatory affairs by the American Board of Toxicology (DABT) and the Regulatory Affairs Professional Society (RAC). When necessary, biocompatibility-testing programs are designed and conducted in compliance with Food and Drug Administration medical device regulations and guidance documents, International Organization for Standardization (ISO) 10993 standards and FDA and international Good Laboratory Practice regulations.

Our medical device consulting services are highly dedicated to our clients’ satisfaction, and we take great pride in the superior results and on time performance that we consistently deliver throughout every phase of our consulting services. Our strong backgrounds in regulatory affairs, preclinical safety, toxicology and biocompatibility, together with our protocol review services, provide assurance that our client’s products will move quickly through the regulatory process.

Our results speak for themselves, as the majority of our 510(k) submissions have been approved within 90 days. Please contact our medical device consultants to ensure the success of your medical device development program.

For more information regarding how we can assist you as medical device consultants with your medical device development issues please contact Dr. Robert J. Staab (phone: 860-434-5872; email: rta1ali1@aol.com) or Dr. Ira Daly (phone: 908-236-6834; email: idaly61127@aol.com).